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PRODIGY: A Phase III Study of Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 Versus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer

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Abstract
PURPOSE Adjuvant chemotherapy after D2 gastrectomy is standard for resectable locally advanced gastric cancer (LAGC) in Asia. Based on positive findings for perioperative chemotherapy in European phase III studies, the phase III PRODIGY study (ClinicalTrials.gov identifier: NCT01515748) investigated whether neoadjuvant docetaxel, oxaliplatin, and S-1 (DOS) followed by surgery and adjuvant S-1 could improve outcomes versus standard treatment in Korean patients with resectable LAGC.

PATIENTS AND METHODS Patients 20-75 years of age, with Eastern Cooperative Oncology Group performance status 0-1, and with histologically confirmed primary gastric or gastroesophageal junction adenocarcinoma (clinical TNM staging: T2-3N+or T4Nany) were randomly assigned to D2 surgery followed by adjuvant S-1 (40-60 mg orally twice a day, days 1-28 every 6 weeks for eight cycles; SC group) or neoadjuvant DOS (docetaxel 50 mg/m(2), oxaliplatin 100 mg/m(2) intravenously day 1, S-1 40 mg/m(2) orally twice a day, days 1-14 every 3 weeks for three cycles) before D2 surgery, followed by adjuvant S-1 (CSC group). The primary objective was progression-free survival (PFS) with CSC versus SC. Two sensitivity analyses were performed: intent-to-treat and landmark PFS analysis.

RESULTS Between January 18, 2012, and January 2, 2017, 266 patients were randomly assigned to CSC and 264 to SC at 18 Korean study sites; 238 and 246 patients, respectively, were treated (full analysis set). Follow-up was ongoing in 176 patients at data cutoff (January 21, 2019; median follow-up 38.6 months [interquartile range, 23.5-62.1]). CSC improved PFS versus SC (adjusted hazard ratio, 0.70; 95% CI, 0.52 to 0.95; stratified log-rank P = 5.023). Sensitivity analyses confirmed these findings. Treatments were well tolerated. Two grade 5 adverse events (febrile neutropenia and dyspnea) occurred during neoadjuvant treatment.

CONCLUSION PRODIGY showed that neoadjuvant DOS chemotherapy, as part of perioperative chemotherapy, is effective and tolerable in Korean patients with LAGC. (C) 2021 by American Society of Clinical Oncology
Author(s)
강윤구국명철김균지김범수김용우김인호김종광김진용김학규김현기노성훈라선영류백렬류성완박영규박영수박조현범성훈설지영손태일오상철유문원유민희유창학육정환이남수이상호이연주이종석이지훈장대영장우진정미란정익주조상희최진혁허미화
Issued Date
2021
Type
Article
Keyword
Adenocarcinoma - mortalityAdenocarcinoma - pathologyAdenocarcinoma - therapyAdultAgedAntineoplastic Combined Chemotherapy Protocols - adverse effectsAntineoplastic Combined Chemotherapy Protocols - therapeutic useChemotherapyAdjuvantDocetaxel - adverse effectsDocetaxel - therapeutic useDrug CombinationsEsophagogastric Junction - drug effectsEsophagogastric Junction - pathologyEsophagogastric Junction - surgeryFemaleGastrectomy - adverse effectsGastrectomy - mortalityHumansMaleMiddle AgedNeoadjuvant Therapy - adverse effectsNeoadjuvant Therapy - mortalityNeoplasm StagingOxaliplatin - adverse effectsOxaliplatin - therapeutic useOxonic Acid - adverse effectsOxonic Acid - therapeutic use Progression-Free SurvivalRepublic of KoreaStomach Neoplasms - mortalityStomachNeoplasms - pathologyStomach Neoplasms - therapyTegafur - adverse effectsTegafur - therapeutic useTime FactorsYoung Adult
DOI
10.1200/JCO.20.02914
URI
https://oak.ulsan.ac.kr/handle/2021.oak/8311
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_proquest_miscellaneous_2542359238&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,PRODIGY:%20A%20Phase%20III%20Study%20of%20Neoadjuvant%20Docetaxel,%20Oxaliplatin,%20and%20S-1%20Plus%20Surgery%20and%20Adjuvant%20S-1%20Versus%20Surgery%20and%20Adjuvant%20S-1%20for%20Resectable%20Advanced%20Gastric%20Cancer&offset=0&pcAvailability=true
Publisher
JOURNAL OF CLINICAL ONCOLOGY
Location
미국
Language
영어
ISSN
0732-183X
Citation Volume
39
Citation Number
26
Citation Start Page
2903
Citation End Page
2903
Appears in Collections:
Medicine > Medicine
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